Quality Engineer - Katalyst Healthcares and Life Sciences : Job Details

Quality Engineer

Katalyst Healthcares and Life Sciences

Job Location : Charlton,MA, USA

Posted on : 2025-08-05T07:38:07Z

Job Description :
Responsibilities:
  • Responsible for performing various Quality Engineering activities whose main purpose is to facilitate continuous improvement for both products and processes and to support new product/process development activities.
  • These activities include process validation, defect analysis and corrective action, new product evaluation, performing internal audits to verify compliance with ISO and FDA/QSR Regulations, personnel training, and developing and implementing improved test and measurement techniques.
  • ll employees are expected to be knowledgeable about and follow the Company's Equal Employment and Affirmative Action Policies, including policies on the rights of individuals with disabilities and harassment.
  • Oversight of various quality systems including, but not limited to, nonconforming material, audits, management review, external standards, and/or document management.
  • Identification of quality issues and resolution support.
  • Review of test protocols and/or process validation protocols and reports.
  • Preparation and analysis of quality data and metrics.
  • Support of internal audits of systems, products, and processes.
  • Preparation and support of external/regulatory audits.
  • Preparation of engineering changes.
  • Provide training and direction to manufacturing and QA personnel.
  • Participate in MRB meetings.
  • Support nonconforming material disposition.
  • CAPA maintenance including investigation support, and/or corrective action ownership.
  • Support quality/manufacturing related improvement efforts.
  • Must be an independent worker, capable of meeting goals and objectives as defined by Management.
  • wareness of practices and processes utilizing current management tools.
Requirements:
  • BS Degree in a Technical / an Engineering discipline.
  • Three years minimum experience within a manufacturing environment, with experience in manufacturing, quality, or process engineering preferred. Medical device experience preferred. CQE certification a plus.
  • Must have knowledge of ISO 13485 and FDA/QSR Regulations.
  • Strong computer skills with software applications for Microsoft Windows including Excel, Word and Minitab.
  • Knowledge of Six Sigma and Lean manufacturing preferred.
  • bility to communicate effectively with personnel at all levels both verbally and in writing.
  • CAPA experience is key.
  • udit experience.
  • ISO 13485 experience.
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